This means that medical devices bearing a CE marking can circulate freely throughout the EU without any barriers Examples of other products regulated by New Approach directives include pressure vessels toys and personal protective equipment The underlying principle of the New Approach is as follows Each of the medical device directives contains a legislative list of Essential
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The EU Medical Device Regulation (MDR) takes effect in Q2 of 2020 In the meantime companies with devices marketed under the current MDD must transition to the new MDR With all the changes in the MDR the transition process can be overwhelming RCQ Solutions has the expertise to know how to get the job done RCQ Solutions is equipped with biomedical engineers and 20+ years of experience in
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Subject: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices amending Directive 2001/83/EC Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Official Journal of the European Union L 117 of 5 May 2017) LANGUAGES concerned: All linguistic versions PROCEDURE
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Design change or major constructional changes State of the art Consultant for Technical Documentation You cannot call anyone a master at medical device technical file preparation A group of professionals experienced in EU medical device CE Marking covering core technical areas such as risk analysis validations design shelf-life usability biological evaluation safety chemical
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Overview of CE Marking Process Changes Resulting from the EU MDR Updated Role of the Notified Body Medical Device Classifications Essential Requirements - Safety Performance Requirements Integration of Risk Assessment / Risk Management Conformity assessment Device Vigilance Reporting System MDR Overview (by Article Annex) ISO 13485
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Regulation of medical implants in the EU and UK 5 1 Introduction 1 Effective regulation of medical implants is of paramount importan ce to patient safety in the UK Recent high-profile cases where faul ty medical implants wer e withdrawn from the market such as the Poly Implant Prosthse (PIP) breast implant and DePuy s Articular
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On a regulatory level the EU allows important devices to be placed on the EU market without the CE mark relevant for the fighting of the COVID-19 crisis Those are Products covered by Regulation (EU) 2016/425 on personal protective equipment (PPE) and medical devices covered by the Directive 93/42/EEC (MDD) or Regulation (EU) 2017/745 (MDR)
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The technical documentation provides information on the design manufacture and operation of a product and must contain all the details necessary to demonstrate the product conforms to the applicable requirements If you are the manufacturer there are certain rules that must be followed when placing a product on the market you must: prepare the technical documentation before placing a
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Since the MDR requirements especially those concerning Unique Device Identification (UDI) and changes to Annex I of the regulation are completely new for the EU market many organizations that work with medical devices are in the process of learning these next steps to increase transparency improve traceability and create better patient outcomes
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The European Union's proposed medical device regulation (MDR) will soon replace the EU's Medical Device Directive (93/42/EEC) and the Directive on active implantable medical devices (90/385/EEC) and is likely to result in important changes for medical device manufacturers
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The new Medical Device Regulation (MDR) becomes applicable and enforceable May 2020 allowing for a 3-year transition period After May 2020 all new devices and any devices with an expiring CE mark must comply with the new MDR This means that devices CE marked under the old MDD or AIMDD may no longer be marketed or put into service unless they have been resubmitted and fully comply with the
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With the European Union (EU)'s new Medical Device Regulation (MDR) taking effect in May 2020 device manufacturers transitioning to the EU MDR face a host of questions Among them are: Is it possible to avoid compliance with the MDR?
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Human Use (OJ L 311 of 38 11 2001 p 67) last amended by Regulation (EC) No 1394/2007 (OJ L 324 of 10 12 2007 p 121) and which complementing the product can have an action on the human body 4 An in vitro diagnostic medical device is a medical device which is intended to be used
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The same responsibilities apply to any other medication tool device or implant that claims to have medical or health care benefits and this forms the basis of the modern pharmaceutical and medical device regulation system In Australia this is managed by the Therapeutic Goods Administration (TGA)
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Regulatory changes in the European Union (EU) Medical Device Directives (MDD)take on unique characteristics when implemented in different EU members states These differences are highlighted by a review of the four leading EU nations—Germany United Kingdom France and Italy The research introduces variance in the product classification of the Advanced Therapy Medicinal Product and
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With the European Union (EU)'s new Medical Device Regulation (MDR) taking effect in May 2020 device manufacturers transitioning to the EU MDR face a host of questions Among them are: Is it possible to avoid compliance with the MDR?
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CE: ACPE 1 25 Knowledge UAN: 0286-0000-19-655-L04-P CME 1 25 IACET 1 25 RN 1 25 Since 2017 we have analyzed the new EU Medical Devices Regulations the enabling acts (still to come!) and MDUFA IV Now one more year on we examine what has improved where action is still required and what to do now to keep products on the market and review new initiatives in Japan Learning
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MDCG 2019-7: Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a 'person responsible for regulatory compliance' (PRRC) MDCG 2019-8: Guidance document implant card on the application of Article 18 Regulation (EU) 2017/745 on medical
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Die Verordnung (EU) 2017/745 ber Medizinprodukte ist am 25 Mai 2017 in Kraft getreten Sie wird auch Medical Device Regulation (MDR) oder europische Medizinprodukte-Verordnung genannt Sie gilt in den Mitgliedstaaten der Europischen Union unmittelbar und muss daher nicht in nationales Recht umgesetzt werden Gleichwohl werden umfngliche Anpassungen des nationalen
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Both Medical Device Regulation and In-vitro Diagnostic Medical Device Regulation establish the need for the notified body to assess technical documentation for a number of devices prior to issuing the certificate 02 Dec 2019 DEKRA's Dutch Notified Body achieves MDR designation One more Netherlands-based Notified Bodies DEKRA Certification B V has obtained designation to issue CE
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MDCG 2019-7: Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a 'person responsible for regulatory compliance' (PRRC) MDCG 2019-8: Guidance document implant card on the application of Article 18 Regulation (EU) 2017/745 on medical
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The new Medical Device Regulation is complex and the changes it embodies are significant Our white paper serves as a first step for medical device manufacturers in the EU Market to better understand the immediate MDR implications by: Analyzing the most influential changes and highlighting their implications for regulated medical device companies Providing practical steps that medical device
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To help manufacturers determine whether the change to the purpose (destination) or the design of their device is a "significant change" as referred to in Art 120 (3) of Regulation (EU) 2017/745 GMED (French Notified Body CE 0459) has published a guide EUROPEAN UNION: Interpretative guide for "significant changes" under
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products that integrate a medical device par t compliance with the general safety and perfor mance requirements laid down in this Regulation for the device par t should be adequately assessed in the context of the marketing author isation for such medicinal products Directive 2001/83/EC should therefore be amended L 117/2 EN Official Jour nal of the European Union 5 5 2017 (1) Regulation
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This means that medical devices bearing a CE marking can circulate freely throughout the EU without any barriers Examples of other products regulated by New Approach directives include pressure vessels toys and personal protective equipment The underlying principle of the New Approach is as follows Each of the medical device directives contains a legislative list of Essential
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Since the EU Medical Device Regulation (EU MDR) introduced the concept of "Economic Operators" (EOs) companies have had to work to understand and implement the requirements for these entities However according to a 2019 study over a quarter (28%) of medical device manufacturers surveyed had not yet started to address these requirements for EOs or to identify the specific entities
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MEDICAL DEVICE MAKERS based in Ireland are ramping up their recruitment measures to meet stringent new EU regulations that are just months away US manufacturer Cook Medical is hiring 20 new full-time roles in its Limerick base which is largely responsible for compliance with the EU's Medical Device Regulation (MDR)
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European Medical Device Regulations Preparing for the Storm Moderator: • A new regulation in Europe for medical devices and in vitro diagnostic products with many changes compared to the current directives • Consolidated trilogue text of EU MDR and EU IVDR were issued in June 2016 and was published in the Official Journal of the European Union in May 2017 Why is EU MDR important
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Combined Online Training for the RA/QA Professionals of the Medical Device Industry: European Medical Device Regulation 2017/745 and Clinical Evaluation Reports (CER) GMED North America has designed a comprehensive 3- day online training course to help companies prepare for their application to obtain and/or maintain CE marking for their medical device product(s) and tools to manage their CER
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Following on from being the first EU notified body in the world to achieve designation to the Medical Devices Regulation BSI was informed on 6 November by the Dutch Ministry of Health (VWS) that its Netherlands notified body is also now designated to the new MDR (EU
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